A Phase II Study of Tri-weekly Low-dose Nab-paclitaxel Chemotherapy for Patients with Advanced Gastric Cancer

Autor: Masazumi Takahashi, Takeharu Yamanaka, Yoshiro Fujii, Hiroshi Miyamoto, Ryo Takagawa, Kei Sato, Jun Kimura, Yusaku Tanaka, Takashi Kosaka, Itaru Endo, Chikara Kunisaki, Sho Sato, Yusuke Saigusa, Hirotoshi Akiyama, Masataka Taguri, Norio Yukawa
Rok vydání: 2018
Předmět:
Zdroj: Anticancer Research. 38:6911-6917
ISSN: 1791-7530
0250-7005
DOI: 10.21873/anticanres.13068
Popis: Background/aim Nanoparticle albumin-bound (nab)-paclitaxel has demonstrated antitumor activity against advanced gastric cancer. However, gastric cancer patients can be difficult to treat with the recommended dose because of the high incidence of adverse toxicities. The aim of this study was to evaluate the safety and effectiveness of low-dose nab-paclitaxel in a multicenter, single-arm, phase II study. Patients and methods Treatment included low doses of 180 mg/m2 nab-paclitaxel administered on day 1 of each 21-day cycle. The primary endpoint was defined as the overall response rate (ORR). The secondary endpoints included progression-free survival (PFS), safety, and overall survival (OS). A total of 34 patients were enrolled in the full-analysis set. Results The ORR was 5.9%. The median PFS and OS were 2.4 months and 9.2 months, respectively. The most common grade 3/4 toxicities were anemia (8.8%), neutropenia (5.9%), appetite loss (5.9%) and peripheral sensory neuropathy (5.9%). No treatment-related deaths occurred. Conclusion The tri-weekly low dose of nab-paclitaxel therapy is effective towards advanced gastric cancer patients with good tolerability and an acceptable margin of safety.
Databáze: OpenAIRE